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Evaluation of the LMA Position Using Ultrasound in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01655459
First received: July 24, 2012
Last updated: July 29, 2012
Last verified: July 2012
  Purpose

Introduction: Although the LMA insertion is not difficult and majority of the cases with LMA fare well in ventilation, the FOB assessment demonstrates a high incidence of LMA malpositioning. The LMA must be seated at the laryngeal inlet with the occlusion of esophageal inlet by the inflated tip. When we meet the signs of LMA malposition, we then reinsert the LMA. The laryngoscopic grading of Rowbottom et al. is commonly used for LMA position, but the rotated degree of LMA was not considered in that grading. We hypothesized that the LMA can affect the position of the arytenoids/thyroid cartilages and it may be detected on ultrasound. This study was designed to assess the predictability of the rotated LMA according to the position change of arytenoids/thyroid cartilages using ultrasound.

Methods: Children, aged 1 ms - 6 years, undergoing infraumbilical surgery were enrolled to this study. Ultrasound was performed on supraglottic and vocal cords area before and after LMA insertion. Transverse images were obtained on end-expiratory phase. LMA-position was evaluated with Bonfils fiberscopy. Position grading was made as usual. If grade >3 was showed, LMA was repositioned while fiberscopic watching. If the face of LMA was rotated to one-side, the LMA was rotated to the opposite side a little. The ultrasound findings of pre- and post-LMA were compared. On fiberscopic images, conventional LMA grade and the degree of rotation were measured.


Condition Intervention
Infraumbilical Surgeries
Procedure: Ultrasound exam of upper airway

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • changes of Ultrasound image of upper airway after Fiberoptic bronchoscopic grade of LMA insertion. [ Time Frame: After the induction of general anesthesia, ultasound image was gained before and after the LMA insertion. Fiberoptic bronchoscpy was done after the LMA insertion. ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ultrasound exam of upper airway
Following Internal Review Board approval(4-2011-0800) and written informed consent, total 100 patients(ASA I and II children aged 1 month to 6years) undergoing infra-umblicular urologic surgeries were included in the study. Children with upper respiratory tract infection, restricted mouth opening, congenital heart disease and those at risk for aspiration were excluded.
Procedure: Ultrasound exam of upper airway
LMA-position was evaluated with fiberoptic laryngoscopy. The ultrasound findings of pre- and post-LMA were compared.

  Eligibility

Ages Eligible for Study:   1 Year to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Following Internal Review Board approval(4-2011-0800) and written informed consent, total 100 patients(ASA I and II children aged 1 month to 6years) undergoing infra-umblicular urologic surgeries were included in the study. Children with upper respiratory tract infection, restricted mouth opening, congenital heart disease and those at risk for aspiration were excluded.

Criteria

Inclusion Criteria:

  • Aged 1 ms - 6 years,
  • undergoing infraumbilical surgery

Exclusion Criteria:

  • coagulopathy
  • pathologic lesions on neck or upper airway
  • mallampati class III or IV
  • difficult airway past history
  • high risk group of aspiration pneumonitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01655459     History of Changes
Other Study ID Numbers: 4-2011-0800
Study First Received: July 24, 2012
Last Updated: July 29, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
ultrasound, LMA, fiberoptic bronchoscopy

ClinicalTrials.gov processed this record on November 24, 2014